Senior Program Engineer (Injection Moulding)

Private Advertiser; Kulai; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading manufacturer in the medical device industry is seeking an experienced Senior Program Engineer to manage injection moulding and tooling operations. The role involves leading product introduction projects, optimizing processes for quality and efficiency, and working closely with various stakeholders. Ideal candidates will have at least 3 years of experience in injection molding and strong knowledge of mold design and process validation.

Qualifications

• Minimum 3 years of experience in injection molding (rubber/silicone) for medical devices.
• Strong knowledge of mold design and process validation (IQ/OQ/PQ).

Responsibilities

• Lead and manage new product introduction projects for rubber injection molding components.
• Serve as the technical liaison between customers, suppliers, and internal teams.
• Develop and validate injection molding processes in compliance with medical standards.
• Oversee tooling design, mold fabrication, trials, and qualification.
• Optimize molding parameters for part quality and efficiency.
• Collaborate with R&D and quality teams for design-for-manufacturability.
• Lead engineering change management and continuous improvement initiatives.
• Prepare and maintain project documentation.

Skills

Injection moulding process optimization

Technical expertise in tooling design

Project management

Collaboration with R&D

Continuous improvement methodologies

Job description

Senior Program Engineer (Injection Moulding)

We are seeking an experienced Senior Program Engineer to lead and manage all activities related to injection moulding and tooling operations. The ideal candidate will have strong technical expertise in tooling design, maintenance, and process optimization, with a focus on product quality, efficiency, and cost control.

Key Responsibilities

• Lead and manage new product introduction (NPI) projects for rubber injection molding components in the medical device industry.
• Serve as the technical liaison between customers, suppliers, and internal teams throughout the project lifecycle.
• Develop and validate injection molding processes for silicone and rubber materials in compliance with medical standards (ISO 13485, FDA).
• Oversee tooling design, mold fabrication, trials, and qualification (IQ/OQ/PQ).
• Optimize molding parameters to ensure part quality, process stability, and cycle time efficiency.
• Collaborate with R&D and quality teams to ensure design‑for‑manufacturability (DFM) and process validation.
• Lead engineering change management and continuous improvement initiatives (DOE, Kaizen, Lean, Six Sigma).
• Prepare and maintain project documentation, including FMEA, validation reports, and process flow diagrams.
• Support cost estimation, quoting, and timeline development for new programs.

Qualifications

• Minimum 3 years of experience in injection molding (rubber/silicone) for medical device or precision component manufacturing.
• Strong knowledge of mold design, rubber materials, and process validation (IQ/OQ/PQ).